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Trial record 1 of 1 for:    NCT01169467
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Cerebral Perfusion Pressure Using Precedex and Other Sedatives (C3PO)

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ClinicalTrials.gov Identifier: NCT01169467
Recruitment Status : Completed
First Posted : July 26, 2010
Results First Posted : November 1, 2015
Last Update Posted : November 1, 2015
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 22, 2010
First Posted Date  ICMJE July 26, 2010
Results First Submitted Date  ICMJE November 5, 2014
Results First Posted Date  ICMJE November 1, 2015
Last Update Posted Date November 1, 2015
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • Variability of Intracranial Pressure (ICP) [ Time Frame: Baseline to 24 hours ]
    Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
  • Change in Pressure Reactivity Index (PRx) [ Time Frame: Baseline to 24 hours ]
    Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP). A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Cerebro-vascular Pressure Reactivity Index [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury [ Time Frame: 24 hours ]
    Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.
  • Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury [ Time Frame: Baseline to 24 hours ]
    Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.
  • Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury [ Time Frame: Baseline to 24 hours ]
    Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Official Title  ICMJE Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Brief Summary The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Detailed Description

Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Endotracheal Intubation
  • Continuous IV Sedation
  • ICP Monitoring
Intervention  ICMJE
  • Drug: Standard-of-Care plus Dexmedetomidine
    Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
    Other Name: Precedex
  • Other: Standard-of-Care
    Subjects who are treated with the standard of care sedation regiment only.
Study Arms  ICMJE
  • Active Comparator: Standard-of-Care plus Precedex
    Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.
    Intervention: Drug: Standard-of-Care plus Dexmedetomidine
  • Placebo Comparator: Standard-of-Care
    Subjects who are treated with the standard of care sedation regiment only.
    Intervention: Other: Standard-of-Care
Publications * Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2013)
89
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
100
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Admitted to Duke University Neuro Critical Care Unit (NCCU)
  • Adult (18 years of age or older)
  • Expected Mechanical Ventilation for >48 hours with sedation
  • Intraventricular catheter in situ

Exclusion Criteria:

  • Hypersensitivity to study drugs
  • Prisoners
  • Moribund state or death expected within 24 hours
  • Surgery planned within 24 hours of subject enrollment
  • Receiving study drug, Precedex, prior to entering study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169467
Other Study ID Numbers  ICMJE Pro00018317
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Keith Dombrowski, MD Duke University
PRS Account Duke University
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP